Key Highlights

  • Capricor Therapeutics shares closed up 8% at $6.80.
  • The FDA pushed the Deramiocel PDUFA date for DMD to November 22, 2026, a three-month extension.
  • The extension follows submission of a major BLA amendment containing long-term HOPE-3 extension data.
  • The additional review period allows CBER to evaluate refined upper-limb efficacy analyses.

Capricor Therapeutics, Inc. (NASDAQ: CAPR) shares closed up 8% at $6.80 after the FDA pushed the Deramiocel PDUFA date for DMD to November 22, 2026, a three-month extension following the submission of a major BLA amendment containing long-term HOPE-3 extension data.

What Happened

The additional review period allows CBER to evaluate refined upper-limb efficacy analyses while maintaining the regulatory path toward potential approval later this year.

Market Reaction

Shares rose as investors responded positively to the extension being tied to the submission of additional supportive data rather than a rejection or major setback, viewing the regulatory path as still intact.

Outlook

The new November 22, 2026 PDUFA date represents the next major disclosed regulatory milestone for Deramiocel in DMD.